75 mg / 1.5 mL concentrate and diluent to concentrate for infusion solution 
amsacrine

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Amekrin is and what it is used for 
2. What you need to know before you use Amekrin 
3. How to use Amekrin 
4. Possible side effects 
5. How to store Amekrin 
6. Contents of the packaging and other information 

1. What Amekrin is and what it is used for

Amekrin belongs to a group of medicines called cytostatics (medicines used to treat cancer).

It is used to treat acute myeloid leukemia, also called AML. AML is a type of blood and bone marrow cancer.

Amekrin is used in adults when the disease has not responded to other treatments or in relapses.

Amsakrin contained in Amekrin may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions and always follow their instructions.

2. What you need to know before you use Amekrin

Do not use Amekrin

  • if you are allergic to amsacrine or acridine derivatives or any of the other ingredients of this medicine (listed in section 6).
  • if you are already receiving (or have recently received) other cancer treatments
  • if you are breast-feeding.

Talk to your doctor before using this medicine if any of the above apply to you.

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before you are treated with Amekrin.

Your doctor will be especially careful if any of the following apply to you.

  • You have had kidney or liver disease.
  • You have a heart problem.
  • You have been told that the potassium level in your blood is too low.
  • You suffer from porphyria ( porphyria is an unusual disease that occurs when a certain enzyme is not formed in a sufficient amount in the liver).

Talk to your doctor before using this medicine if any of the above apply to you.

Children and young people

Amekrin should only be used by adults. Amekrin should not be used by children and adolescents under 18 years of age.

Regular examinations

Your doctor will perform regular medical examinations, e.g. blood tests to check the number of blood cells and kidney and liver function as well as examinations of the heart.

Other drugs and Amekrin

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

A large number of drugs can interact with Amekrin and have markedly altered effects. Some examples:

  • Influenza and pneumococcal vaccine ( pneumococci are bacteria that can lead to pneumonia, for example )
  • Live vaccines
  • Other drugs used to treat cancer
  • Methotrexate is used to treat, among other things, cancer and rheumatoid arthritis

If you are already taking any of these medicines, talk to your doctor before receiving Amekrin.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

During pregnancy, this medicine should only be given if absolutely necessary. The benefits of treatment must be weighed against the risk to your unborn child.

Precautions regarding pregnancy for men and women

Women of childbearing potential must use effective contraception during and up to three months after stopping treatment. Men must use effective contraceptive during and up to six months after stopping treatment.

Breast-feeding

Do not breast-feed while receiving Amekrin.

Fertility

There is some evidence to suggest that amsacrine has a negative effect on female fertility. Some evidence suggests that male fertility may be temporarily adversely affected.

Driving and using machines

Amekrin is unlikely to affect your ability to drive or use machines. If you experience side effects such as headache and dizziness after the infusion has been given to you, be careful when driving or using machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

3. How to use Amekrin

You will normally be given Amekrin in a hospital by a doctor or nurse who has experience in the use of chemotherapy.

Amekrin is injected slowly as an infusion into a vein for 1-2 hours.

Dose one is calculated by your doctor based on your age and body surface area (normally 300-650 mg per square meter per treatment period).

Initial treatment

You will receive one infusion per day for 3-7 days.

Further treatment

After the initial treatment period, additional doses are given depending on the number of blood cells in your blood.

If Amekrin reduces the number of blood cells too much, your doctor may need to give you a blood transfusion.

If you have any further questions on the use of this product, ask your doctor.

If you use more Amekrin than you should  

Because infusion one will be given under the supervision of a doctor, it is unlikely that you will receive more than necessary. Talk to your doctor if you are worried about dosing one of the medicines.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

All medicines can cause allergic reactions, although severe allergic reactions are rare. Sudden wheezing, difficulty breathing, swelling of the eyelids, face or lips, rash or itching (especially if the rash or itching affects the whole body) should be reported to a doctor immediately.

Very common (may affect more than 1 user in 10)

  • Minor bleeding from the skin and mucous membranes
  • Diarrhea, stomach ache
  • Low blood pressure
  • Pain and swelling at the injection site due to inflammation of a blood vessel
  • Elevated liver values
  • Inflammation of the mouth
  • Nausea, vomiting.

Common (may affect up to 1 in 10 people)

  • Severe reduction in blood cell s that can cause weakness, bruising or bleeding, or increase the risk of infection s
  • Bleeding
  • Severe heart problems (eg heart failure causing shortness of breath), irregular heartbeat
  • Attack
  • Hepatitis, jaundice (causes skin and whites of the eyes to turn yellow), impaired liver function
  • Blood in the urine
  • Skin loss, dermatitis
  • Infection
  • Fever
  • Shortness of breath
  • Low potassium levels can cause muscle weakness, twitching, or abnormal heart rhythm
  • Mood swings
  • Hair loss
  • Hives, rash
  • Irritation at the injection site.

Rare (may affect up to 1 in 1,000 people):

  • Other serious heart problems (eg life-threatening irregular heartbeat, palpitations, slow heartbeat, ECG changes)
  • Anemia, a decrease in red blood cells that can lead to pale skin, weakness, or shortness of breath
  • Severe reduction in white blood cells which increases the risk of infection s
  • Severe allergic reaction, swelling due to excess fluid in the body, hypersensitivity
  • Renal impairment (eg urinary incontinence, renal failure )
  • Weight loss, weight gain
  • Lethargy (extreme fatigue or drowsiness), confusion
  • Headache, dizziness
  • Decreased touch sensitivity or touch
  • A nerve disorder that can lead to weakness, tingling, or numbness
  • Visual disturbances
  • Egg whites in the urine
  • Abnormal liver and kidney values

No known frequency (cannot be calculated from the available data)

  • High levels of uric acid in the blood

The above list of possible side effects may seem daunting, but acute leukemia is a serious illness that requires aggressive treatment.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Amekrin

Keep this medicine out of the sight and reach of children.

Do not store above 25 ° C.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content Declaration for Amekrin

  • The active substance is amsacrine. Each ml of concentrate for solution for infusion contains 50 mg of amacrin. Each vial contains 75 mg of amsacrine.
  • The other ingredients are N, N-dimethylacetamide, lactic acid, and water for injections. 

What the medicine looks like and contents of the pack

Amekrin delivered in sets of one vial of clear glass with a concentrate and a vial of clear glass with liquid. The concentrate vial contains the active substance amsacrine and N, N-dimethylacetamide in 1.5 ml clear orange / red liquid.

The vial of liquid contains 13.5 ml solution of lactic acid in water for injections as a clear solution.

Pack size

1 x 6 vials of concentrate for solution for infusion and 6 vials of liquid for solution for infusion.

Marketing Authorization Holder and Manufacturer

Eurocept International BV

Trapgans 5

1244 RL Ankeveen

Netherlands

This medicinal product is authorized under the European Economic Area under the names:

Name of Member State Name of the medicine
Austria Amsidyl 75 mg / 1.5 ml concentrate and solvent for concentrate for solution for infusion
Belgium Amsidine 75 mg / 1.5 ml concentrate and solvent for solution for infusion
Czech Republic Amsidyl 75 mg / 1.5 ml ml concentrate and rosemary concentrate for infused rosemary
Denmark Amekrin 75 mg / 1.5 ml concentrate and solvent for concentrate for solution for infusion 
Finland Amekrin 75 mg / 1.5 ml infusioconcentrate and liuotin, infusion concentrate liuosta varten
Germany Amsidyl 75 mg concentrate for the preparation of an infusion solution
Iceland Amekrin 75 mg / 1.5 ml Concentrate and solvent for concentrate for solution for infusion
Ireland Amsidine concentrate and solvent for solution for infusion 50 mg/ml
Italy Amsadina 75 mg / 1.5 ml concentrate and solvent per concentrate per solution per infusion
Luxembourg Amsidine 75 mg / 1.5 ml diluted and solvent solution for perfusion
Malta Amsidine Concentrate in Solvent Gel Solutions 50 mg / ml Infusion
Netherlands Amsidine concentrate and solvent for solution for infusion 75 mg / 1.5 ml
Norway Amekrin 75 mg / 1.5 ml concentrate and liquid for concentrate for solution for infusion
Poland Amsidyl 75 mg / 1.5 ml concentrate and concentrate for concentrates and infusion preparations
Portugal Amekrin 75 mg / 1.5 ml concentrate and solvent for concentration for perfusion
Slovakia Amsidyl 75 mg / 1.5 ml concentrate and suspension for infusion concentrate
Spain Amekrin 75 mg / 1.5 ml concentrate and solvent for solution for perfusion
UK Amsidine concentrate and solvent for solution for infusion 50 mg / ml

Muhammad Nadeem

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